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ELSI and Stem Cells Research

ELSI and Stem Cells Research. To do or not to do or how to do it Somsak Chunharas. Why ELSI and Advanced Bio-medical Research. Generic double-edged nature of scientific discoveries well documented in human history

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ELSI and Stem Cells Research

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  1. ELSI and Stem Cells Research To do or not to do or how to do it Somsak Chunharas

  2. Why ELSI and Advanced Bio-medical Research • Generic double-edged nature of scientific discoveries well documented in human history • Knowledge about the most basic unit of life unique to individual may be difficult to handle • Prevailing values towards life and society ( what is life/eugenic/survival of the fittest/inter-dependent/coexistence) will undoubtedly dictate how we view research and its results STEM CELL ELSI

  3. Why ELSI and Advanced Bio-medical Research • Society has become more skeptic about scientific progress and collective good that can be attained • Intellectual properties sharing is becoming a more complex issue – who are entitled to share the benefits • Commercialization of scientific progresses STEM CELL ELSI

  4. From sciences point of view, neglect of ELSI will eventually deter scientific progress From society point of view, failure to handle ELSI properly will lead to lost opportunities STEM CELL ELSI

  5. Facing Our Fundamental Values towards Life and Living • How do we view conception? When does “human life” begin? • How much do we favour eugenics? • Relationship between individuals in the society : domination and exploit or care and help STEM CELL ELSI

  6. Facing Our Fundamental Values towards Life and Living • How do we live and deal with “risk”? • Fundamentalism or Pragmatism : can our values about life and living shift and change to accommodate/embrace new technologies? STEM CELL ELSI

  7. ELSI Issues in (Embryonic) Stem Cell Research • What is life? What do we consider as human? What is the the status of an embryo? • Who owns embryo? • Commercialization of human parts/tissues – sperms and eggs (for production of embryo) • Living spare parts – human right and dignity • Somatic cell transfer of human cells STEM CELL ELSI

  8. Difficult Questions that Need to be Addressed • Can we do research on embryo at the expenses of a potential human life? • Is it ethical to trade a (potential) human life with a potential treatment? • Is it ethical to fertilize embryo purposefully for stem cell harvesting? STEM CELL ELSI

  9. Difficult Questions that Need to be Addressed • Is it ethical to use already fertilized ovum (through IVF) for stem cells? Who has the right to those embryos? • Is it ethical to do somatic cell nuclear transfer to produce stem cell? Is it possible to prevent them from being used for cloning new human beings? • Is it ethical to sell eggs and sperms? STEM CELL ELSI

  10. What have been done to address the issues? • Consulting religious groups – no single set of values towards the beginning of life • Consulting the legal experts – different rulings re the use of (thawed) embryo and commercialization of eggs and sperms and other human tissues • consulting the society – inadequately informed and too diverse value to reach consensus STEM CELL ELSI

  11. Religious Views about the beginning of Life • Islam • 120 days after fertilization • relative benefits to be weighted • Buddhist • depending on who you asked • no concept of fertilization and embryo • 3 conditions for the beginning of human life • Christianity • catholic – absolutely non-negotiable • scientists – 14 days after fertilization STEM CELL ELSI

  12. NOT ONLY No single set of values and judgment across religions BUT No single (unanimous) value and judgment within each religion ALSO No single (unanimous) values even among those belonging to the same religion in the same country STEM CELL ELSI

  13. Rulings So Far • Research on embryo • not allowed at all • allowed only for those coming from fertilization not from somatic cell transfer • allowed for those below 14 days (regardless of sources) – England STEM CELL ELSI

  14. Rulings So Far • Use of (thawed) Embryo • acceptable upon consent from both parents • no clear ruling in case of death or divorces • no commercialization is allowed/accepted • unused embryo must be destroyed • unused embryo must be kept indefinitely STEM CELL ELSI

  15. Rulings So Far • Commercialisation and use of eggs and sperms to produce new embryo for ES • no sale of any human tissues are allowed • no explicit ruling against sale of human tissues of any kind • socially unacceptable to sale tissues for health or even research purposes ( donation only) • prohibiting doctors from obtaining eggs for purposes other than IVF • no explicit ruling against IVF for ES STEM CELL ELSI

  16. Rulings So Far • Somatic Cell Nuclear Transfer • absolutely not allowed • allowed for ES harvesting only (therapeutic cloning) but not for reproductive purposes • ruling prohibiting medical personnel to do SCNT • no ruling STEM CELL ELSI

  17. Rulings So Far • Intellectual Property Sharing • Owners of tissues are not entitled to IP benefits though cell lines were produced out of the tissues obtained • there should be explicit statement about IP sharing in the consent form when obtaining tissues for research (whether yes or no) STEM CELL ELSI

  18. Most countries belong to the group “No Explicit Ruling of Any Kind” STEM CELL ELSI

  19. STEM CELL ELSI

  20. Key Infrastructure Needed(I) • (Re)inventing key social institution • the media • S&T authoritative bodies • Religious institutions • Educational institutions • Inventing new institutions • National ELSI bodies? vs civic ELSI Groups STEM CELL ELSI

  21. Key Infrastructure Needed(II) • New legislative framework • law governing IVF or Reproductive health in general • law dealing with scientific practices • laws governing medical practitioners • law on intellectual property – international and national • additional rules and regulation in ethical research conduct STEM CELL ELSI

  22. Examples of Guidelines on Selected Issues in Thailand • Sources of Stem Cells • human fetal tissues from spontaneous abortion • human embryos (from IVF) but before reaching stage of mesoderm formation • umbilical cord blood and adult homatopoietic stem cells • fully informed consents needed for all sources • Use limited for specific studies STEM CELL ELSI

  23. Examples of Guidelines on Selected Issues in Thailand • Use of (Thawed) Embryo • Use for research permissible under consent • Consent for research use should be voluntary and donor will put no further claim of ownership • consent for research obtained separately from the treatment process, with no incentives (discount) • Consent should be for specific studies • use for research only when no need for infertility treatment • Embryo with no traceable parents cannot be used STEM CELL ELSI

  24. Aborted Embryos cannot be used for any purposes except from spontaneous abortion STEM CELL ELSI

  25. Examples of Guidelines on Selected Issues in Thailand • Eggs and Sperms acquisition for research • voluntary and fully informed with informed consent of eggs and sperms donation • primary purposes of donation should be for treatment of infertility • no explicit prohibition to use sperms and eggs to directly produce ES for research • Use for ES research should be consented only for left-over embryos STEM CELL ELSI

  26. Examples of Guidelines on Selected Issues in Thailand • SCNT • permissible for ES research but not for reproductive cloning • SCNT across species not allowed • Thai Medical Council prohibited doctors from carrying out cloning(SCNT) for any purposes STEM CELL ELSI

  27. Examples of Guidelines on Selected Issues in Thailand • Use of adult stem cell and umbilicord stem cell for research • acquisition should be on voluntary basis only • donation only with no compensation of any kind • fully informed consent needed for those donation • no subsequent claim of ownership from the side of the donor STEM CELL ELSI

  28. Rules and Regulations on ELSI will be in place before the final successes and failures of all promising advanced research They may affect the speed but not the outcome of scientific development STEM CELL ELSI

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